United States - English - NLM (National Library of Medicine)

physicians total care, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the: - treatment of moderate to severe vasomotor symptoms associated with menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. estradiol/norethindrone acetate tablets 1.0 mg/0.5 mg is also in

United States - English - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e), norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s) - estradiol 1 mg - estradiol/norethindrone acetate tablets are indicated for:   limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol/norethindrone acetate tablets are contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.2)] - breast cancer or history of breast cancer [see warnings and precautions (5.2)] - estrogen-dependent neoplasia [see warnings and precautions (5.2)] - active dvt, pe, or history of these conditions [see warnings and precautions (5.1)] - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions [see warnings and precauti

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol vaginal inserts is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)]. - breast cancer or a history of breast cancer [see warnings and precautions (5.3)]. - estrogen-dependent neoplasia [see warnings and precautions (5.3)]. - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)]. - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)]. - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol vaginal inserts [see warnings and precautions (5.16)]. - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol vaginal inserts are not indicated for use in pregnancy. there are no data with the use of estradiol vaginal inserts in pregnant women; however, epidemiologic studies and meta-analyses have

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 10 ug - estradiol is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding [see warnings and precautions (5.3)] . - breast cancer or history of breast cancer [see warnings and precautions (5.3)] . - estrogen-dependent neoplasia [see warnings and precautions (5.3)] . - active dvt, pe, or history of these conditions [see warnings and precautions (5.2)] . - active arterial thromboembolic disease (for example, stroke or mi), or a history of these conditions [see warnings and precautions (5.2)] . - known anaphylactic reaction, or angioedema, or hypersensitivity to estradiol [see warnings and precautions (5.16)] . - hepatic impairment or disease. - protein c, protein s, or antithrombin deficiency, or other known thrombophilic disorders. risk summary estradiol is not indicated for use in pregnancy. there are no data with the use of estradiol in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol and any potential adverse effects on the breastfed child from estradiol or from the underlying maternal condition. estradiol is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol to determine whether those over 65 years of age differ from younger subjects in their response to estradiol. the women’s health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.2) ] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.2) ] . the women’s health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.4) and clinical studies (14.3) ] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8  [see warnings and precautions (5.4) and clinical studies (14.3) ] . estradiol (ess-tra-dye-ole) vaginal inserts read this instructions for use before you start using estradiol vaginal inserts and  each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. how should i use estradiol vaginal inserts? - estradiol vaginal insert is an insert for use only in the vagina. do not take by mouth. - wash and dry your hands well before handling estradiol vaginal insert. step 1: tear off 1 applicator. step 2: pull apart the plastic wrap and remove the applicator (see figure a). if after opening the package you see that the estradiol vaginal insert has come out of the applicator but has not fallen out of the package, carefully put the insert back into the applicator for insertion. figure a step 3: hold the applicator between your thumb and middle finger. leave your index (pointer) finger free to press the applicator plunger (see figure b). figure b step 4: select the best position for vaginal insertion of estradiol vaginal inserts that is most comfortable for you. for insertion in the lying down position, see figure c. for insertion in the standing position, see figure d figure c figure d step 5: gently insert the end of the applicator into your vagina as far as it will comfortably go or until half of the applicator is inside your vagina, whichever is less. do not use force. if the insert falls out of the applicator before insertion, throw away (dispose of) the insert and applicator. get a new applicator. step 6: while holding the applicator in place, gently press the applicator plunger with your index (pointer) finger until it stops, to release the insert into your vagina. the insert will dissolve. step 7: gently remove the applicator from your vagina and throw away (dispose of) after use. insertion may be done at any time of the day. it is advisable to use the same time daily for all applications of estradiol vaginal inserts. if you have any questions, please ask your healthcare provider or pharmacist. how should i store estradiol vaginal inserts? - store estradiol vaginal inserts at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - do not refrigerate. keep estradiol vaginal inserts and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amneal pharmaceuticals of new york, llc brookhaven, ny 11719 rev. 01-2024-01

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - estradiol transdermal system (twice-weekly) is indicated for:       when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.       when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system (twice-weekly) is contraindicated in women with any of the following conditions: estradiol transdermal system (twice-weekly) is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system (twice-weekly) in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregna

United States - English - NLM (National Library of Medicine)

sandoz inc - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d - estradiol transdermal system is indicated for:   limitations of use: when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.   limitations of use: when prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. consider estrogen therapy only for women at significant risk of osteoporosis. estradiol transdermal system is contraindicated in women with any of the following conditions: risk summary estradiol transdermal system is not indicated for use in pregnancy. there are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary estrogens are present in human milk and can reduce milk production in breast-feeding women. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition. estradiol transdermal system is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration. there have not been sufficient numbers of geriatric women involved in clinical studies utilizing estradiol transdermal system to determine whether those over 65 years of age differ from younger subjects in their response to estradiol transdermal system. the women’s health initiative studies in the whi estrogen-alone substudy (daily ce [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see warnings and precautions (5.1), and clinical studies (14.3)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [seewarnings and precautions (5.1), and clinical studies (14.3)] . the women’s health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.4)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.4)].